MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR PROSTHESIS

Catalog Number	ATC3028
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device.Hence, we cannot conclusively determine the root cause of the defect.We were notified about this incident at (b)(6) hospital located in (b)(6) from our distributor.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this event.There were no non-conforming material reports associated with this crosslinking batch, impregnation lot or the subassemblies associated with this graft.Further, we have not received any complaint from any other customer related to this lot.From the pictures provided by the hospital of the implanted graft, it looks like a normal graft.Graft has been discarded.
Event or Problem Description
Albograft leaked during the procedure.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6324284
• Report Number: 1220948-2017-00008
• Device Sequence Number: 1037295
• Product Code: MAL
• UDI-Device Identifier: 00840663103980
• UDI-Public: 00840663103980
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: ATC3028
• Device Lot Number: 162454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention